Germany· DE-A57-8249a8946419931d
Isomol
A medicinal product containing sodium hydrogen carbonate, potassium chloride, sodium chloride, macrogol 3350, registered in Germany by Norgine Healthcare B.V..
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Sodium Hydrogen Carbonate, Potassium Chloride, Sodium Chloride, Macrogol 3350
- Manufacturer
- Norgine Healthcare B.V.
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sodium hydrogen carbonate, potassium chloride, sodium chloride, macrogol 3350 in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandMacrogol Fairmed Junior, PulverStrides Pharma International AG
- FinlandDuphagolCooper Consumer Health B.V.
- United StatesGaviLyte - CLupin Pharmaceuticals,Inc.
- IrelandLaxido Orange, powder for oral solutionGalen Pharma Ireland Limited
- SwedenAbdomin Citrus Pulver till oral lösning i dospåseOrifarm Healthcare A/S
- NorwayLaxirivaSandoz A/S
- NetherlandsBENLAXID 13,7 g poeder voor drankItalfarmaco, S.A.
- IcelandMovicolNorgine Healthcare B.V.
Authorised across Europe · EMA
The same active substance is authorised in 20 EEA countries. Names it is sold under:
- Austria · Endofalk, Laxogol
- Belgium · Curapeg, Laxido Junior Neutral
- Bulgaria · Ендофалк
- Cyprus · Molaxole
- Denmark · Abdomin Citrus, Abdomin Junior Neutral
- Spain · Acolora, Atolaxant
- Finland · Duphagol, Duphagol Junior
- France · Macrogol 3350 Norgine Enfants, Movicol
- United Kingdom (Northern Ireland) · Compound Macrogol, Compound Macrogol Manx Healthcare
- Greece · Bimotil, Clinitrat
- Ireland · Laxido, Laxido Orange
- Iceland · Movicol, Movicol Junior Neutral
- Italy · Benlaxid, Goganza
- Luxembourg · Laxido Junior Neutral, Laxido Nature
- Malta · Macrolief, Movicol
- Netherlands · Benlaxid, Macrogol En Electrolyten Ratiopharm
- Norway · Abdomin Junior Med Nøytral Smak, Abdomin Med Nøytral Smak
- Poland · Aurogo
- Portugal · Duphagol, Endofalk
- Sweden · Abdomin Citrus, Abdomin Junior Neutral
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of EMA Article 57 (European Union). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/adfaa0a2-ae35-4b12-8cf8-a9d957763cea GET /v1/drugs/adfaa0a2-ae35-4b12-8cf8-a9d957763cea?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"pzn": null,
"route": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Sodium Hydrogen Carbonate, Potassium Chloride, Sodium Chloride, Macrogol 3350",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about sodium hydrogen carbonate, potassium chloride, sodium chloride, macrogol 3350.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.